Surgical suture material and method for the application thereof

ABSTRACT

A surgical suture material and a method to the use thereof are represented by different needles and surgical threads. The main embodiments comprises a needle ( 6 ), consisting of two needles ( 7, 8 ) jointed by a temporary connection having a tetrahedral, diamond or another shape in such a way that a single needle point ( 9 ) is formed, and a surgical thread ( 10 ) provided with shaped design projections embodied on the thread surface in the form of notches. The method consists in introducing, during a surgical intervention, the twin needle in one puncture at a small depth, wherein the needle is divided into two needles, and in leading each needle along a required contour. The surgical suture material can be extensively used for surgical and cosmetic interventions.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 12/300,401, filed Nov. 11, 2008, now U.S. Pat. No. 8,192,462,which is the U.S. National Phase of International Application No.PCT/RU2006/000241, filed May 16, 2006.

BACKGROUND OF THE INVENTION

The invention relates to medicine, to appliances and methods of carryingout surgical operations and manipulations. In particular, the inventionrelates to medicinal materials used in surgery in plastic cosmeticoperations.

Surgical suture material, that is, needles with threads for sewing upthe edges of wounds in surgical operations, threads for cosmeticallytightening soft tissues with needles of different forms or without them,but with special devices for introducing the needles into the tissues,are known:

-   -   Application PCT/RU2004/000252 of Jun. 30, 2004.    -   EP 0205811 A1 of Dec. 30, 1986.    -   RU 2186536 C2    -   U.S. Pat. No. 5,342,376 of Aug. 30, 1994.

The needles are manufactured from metal, most frequently steel, they canbe straight or bent around their circumference, or have another shape.At one end there is a point, while at the other end there is an eye forinserting a surgical suture thread. For sewing up the edges of wounds,atraumatic needles have been used during the past decades, which lackthe eye, while the suture thread is fastened to the needle by anindustrial method, which allows the surgeon to use disposable sterilesuture material, and most importantly a needle which does not comprise abulky eye and a double thread. Such a needle marginally traumatizes thesoft tissues when the needle with the thread is passed therethrough.

The needle can be double-pointed, and the thread can be connected to itin the centre or at the extension. The shape of the needle is determinedby the method of its application in the surgical operation.

The threads, which are atraumatically connected with the needles, can bemanufactured from different non-absorbing or absorbing materials, withdifferent thickness and strength, integrally (in one filament), woven,spun, or coated with a different material.

The general characteristics of surgical needles are: strength, a smoothsurface, biological inertness. They must penetrate the skin easily andpass freely through the subcutaneous tissues. For sewing up open woundsin a continuous suture process, suture materials with bent needles areused, straight needles are not useful in this case.

Surgical needles can be smooth, coarse, and can also have protrusionsarranged at an angle on their surface.

Methods for arranging surgical sutures for sewing up wounds or sewingsubcutaneous tissues are known: interrupted sutures, mattress sutures,continuous sutures, etc. The sewing of subcutaneous tissues is carriedout in the open wound for sewing its edges up, without incisions of theskin through punctures for tightening the soft tissues, and throughshort incisions of the skin when an endoscopic operation is carried out.The latter two approaches are usually employed in aesthetic surgery forsewing and tightening of ptotic subcutaneous tissues and fastening themin a new and higher position, which renders a better aesthetic result.These operations and manipulations are easily and well carried out onlywith suture threads with double-pointed needles.

The known suture material with protrusions for sewing up the edges ofwounds with perpendicular single stitches (U.S. Pat. No. 5,053,047 ofOct. 1, 1991), and also for a continuous subcutaneous and intracutaneoussewing up of wound edges, has some negative properties, which preventthe implementation of quality surgery.

In sewing up open wounds with the method claimed in US WO-A-98/52473 ofMay 21, 1997, the skin edges of the wound are positioned badly withrespect to each other if only subcutaneous sutures are applied. If,however, such sutures are applied intracutaneous, they become visible,and, since the claimed method for sewing wounds does not provide for aremoval of the sutures after the wound is healed, this factor does notallow to obtain an aesthetically acceptable post-operational scar. Afurther downside of said method are the high costs of the operation,since for the same length of the wound, several times the amount ofsuture material is needed compared to the continuous sewing method.

The sewing devices claimed in the US patents are so bulky that it isimpossible to apply continuous sutures and to obtain unobtrusive scarswith them.

The suture material according to EP 1075843 is also fairlyexpensive—with a unit of such suture thread a wound of only 10 cm inlength can be sewn up (else the removal of the thread after the healingof the wound becomes difficult), while sewing up wounds withconventional atraumatic smooth threads is possible for single cuts of7-10 cm with the entire length of suture thread (approximately 45 cm).

According to EP 1 075 843, the amount, strength, and also the durabilityof the engagement of the seams of the second set with the tissues isinsufficient for keeping the free end of the thread from slipping intothe depth of the wound. At the same time, the strength and durability ofthe engagement of the seams of the first set with the tissues isabundant. The fact is that according to the invention each seam on theright and on the left has the same strength, and also the distancebetween them is equal. With each applied stitch, when the thread istightened and the edges of the wound are crimped to some extent, thetension on the very first seam of the second set is gradually increased.At some point it will fail to stand this, will bend or tear, and thethread will slip into the depth of the wound in one turn. If the tensioncontinues to increase, the same will happen to the second seam and soon, hence the end of the thread can slip under the skin. Even if thatdoes not happen, the entire construction can still slacken at theinstant when the operation is finished, and there is a risk that thesuture turns out to be unstable.

According to EP 1 075 843 the conically shaped protrusions claimed inthe invention do not reliably keep the tissues in a tightened state. Thefact is that when the thread is tightened to the opposite side and thepressure on the protrusions is gradually increased, they will spreadout, become arranged perpendicularly with respect to the thread and thenbend, and the thread will slip into the tissue in one or several turns.That is, the protrusions on the threads, when a tightening is carriedout, will not turn into hooks engaging the tissues, but will simply bendaway, as is confirmed in the specification, and this is insufficient fora reliable fixation of the thread with the protrusions in the tissues.This is particularly important for the second group of seams.

In surgical practice there are cases when during the sewing up of awound a considerable force is necessary for contracting the edges. Here,the surgeons have to carry out a wide mobilization of skin-fat patchesfrom both sides of the wound, which is not always technically possible,and also apply a large number of multi-layer and frequent single suturesin the subcutaneous layers as well as on the skin. For wounds spreadingover a large area, single sutures applied on the edges of the wound(especially on subcutaneous fat cell tissues) often get perforated,since with conventional suture needles it is impossible to keep asufficient volume of tissue in the loop.

The wide mobilization of tissues, the application of a large number ofsutures on the edge of the wound and the considerable tension of theskin around the edges of the wound results in additional traumatisationof the edges of the wound as well as of the adjacent portions, prolongsthe process of healing of the wound, increases the risk that its edgesspread out, and finally renders a rough broad scar.

The usage of double-pointed surgical needles (PCT/RU2004/000252 of Jun.30, 2004) for tightening soft tissues showed that this suture materialhas some negative properties.

Although a sewn and tightened portion of flabby soft tissues withoutapparent cuts, without rough retractions of the skin, with an even,smooth contour is obtained, a relapse of deformations occurs fairly soon(after 4-10 months), and the patients are not satisfied with suchshort-lived results. The cause for this failure is that the threads usedfor sewing are smooth and the tissues tightened by them swiftly andeasily slip away downwards.

The “APTOS” threads according to RU 2268752 (PCT/RU 02/00285) also havenegative properties.

When they are used for tightening soft flabby tissues by the meansclaimed in the patent, the results of the operations are alsoshort-lived. The fact is that the protrusions on the “APTOS” threadsaccording to said patent are arranged so that in the tissues one half ofthem works against the other half. Irrespective of whether theseprotrusions are arranged opposite each other on the different halves ofthe thread (left or right of the centre of the length of the thread) orwhether they alternate, their quantity and also the strength of each areoccasionally insufficient for supporting the entire conglomerate of softtissues.

Moreover, when the thread is not guided into the opening of the needlecarefully, the protrusions (especially those which point to the side ofthe movement of the thread) can bend and not spread out in the tissues,which causes a one-sided weakening of the thread engagement.

The weakness of the protrusion is explained by the shortcoming of itsdesign, and the insufficient quantity is explained by the fact that theprotrusions tighten the ptotic tissues only on one half of the length ofthe thread, while the protrusions of the other half fixate and supportthe protrusions of the first half.

Considering these shortcomings of employed suture materials and methodsof their use, it is expedient to employ a new, more effective surgicalmaterial with protrusions on the threads, with the help of which a morereliable sewing of operation wounds with a continuous cosmetic suture ispossible, to apply a new, more effective method of contracting the edgesof such operation wounds, which require a considerable force for doingso, and to employ a new surgical suture material, which allows acombination of the possibilities of the method of internally sewing softtissues with the aid of double-pointed needles and the methods oftightening with “APTOS” threads and protrusions, to suggest new andeffective operations for tightening ptotic tissues of the face, the bodyand the extremities.

SUMMARY OF THE INVENTION

To eliminate the mentioned shortcomings of the suture materials andmethods of their application, a series of versions of new surgicalsuture materials and methods of their application in chirurgical andplastic surgery is suggested.

The suture material comprises a needle of metallic, polymer or organicmaterials and a thread of the same materials with protrusions on thesurface, characterised in that the needle is composed of two needleswhich are temporarily affixed to one another, forming a single needle ofa four-sided, rhomboid or other shape, and, when affixed, forming onepoint, the ends of the thread being attached to the different needlesopposite to the point in such a way that the protrusions of the shapeddesign on the thread are arranged from opposite sides of the latter fromthe centre of the thread with their ends opposite to the attachment ofthe thread in the needles.

Another version of the suture material is characterised in that theneedle is a double-pointed composition, and the thread is fixed by itsends to the central part of the needles at a distance from the points ofthe needles, the protrusions of the shaped design being directed withtheir ends opposite to the attachment of the thread in the needles.

The next version of the suture material is characterised in that theneedle is double-pointed with a thread, the ends of which are attachedto the needles directly at one of the sharp ends.

Another suture material is characterised in that it consists of adouble-pointed needle with a thread with protrusions of a shaped design.

The next version of the suture material comprising a thread ischaracterised in that the thread comprises protrusions, applied with theaid of notches, having a length of approximately 1.5 to 5 times thediameters of the thread with a shaped design of the variablecross-section, amounting at the basis to approximately ¼ of the diameterof the thread from the surface and at the central part to approximately⅓ of the diameter of the thread from the surface with a gradualtransformation to the sharpened end of the protrusion, which allows abending of the protrusion in the form of a fishing hook when the threadis pulled back in the process of sewing soft tissues.

The surgery is carried out with the following methods. In the method ofapplying the suture material for sewing up the edges of wounds requiringforces for contracting the edges of the wounds, the double-pointedneedle with the thread with the inclined protrusions of the shapeddesign is introduced with either point into one of the wound edges up toa predetermined depth, thereafter the needle with the thread is movedparallel to the skin perpendicularly to the wound edge to the necessarydistance from the wound edge, subsequently the point is directed to thesurface of the skin but not extracted entirely, the second pointremaining approximately at the depth of the passage of the thread, and,rotating the needle by an angle of 90°, a rectangular stitch iscontinued to be made, thereafter the same is done on the other edge ofthe wound, the ends of the thread being connected to each other.

The quantity of applied stitches is determined by the necessity ofrendering a reliable fixation of the wound edges and a sufficientcontracting thereof.

The method of sewing up the edges of a wound with suture material in acontinuous cosmetic suture is carried out as follows: The needle isinserted at one of the edges of the wound approximately one centimeteraway from the end of the wound, and the point of the needle is insertedinto the subcutaneous cellular tissue of the wound by a known method,continuous stitches are applied in turns to each of the wound edges,gradually moving to the opposite end of the wound, wherein with eachstitch the thread is tightened with some excess amount of force, whichalso results in a contraction of the wound edges and some weaklydelineated perforation of the tissues, after the sewing of the wound isterminated, the needle is extracted at the opposite end on the surfaceof the skin, if necessary, the thread is additionally tensioned andtrimmed, leaving a portion of at least three centimeters of the threadabove the skin.

The operation of tightening ptotic tissues in the cheek and cheekbonearea of the face consists of the following steps: a localizedpunctuation is made, the needle is inserted into the subcutaneoustissues to the required depth, thereafter the needle is divided in two,and further each needle is led along its contour, and when they arerotated, they are not fully extracted to the surface, they are rotatedand continue the subsequent movement with the other point of the needlealong the other contour, whereby the tissues are tightened. Theextraction of the needles is implemented at the point of the initialpuncture, where the thread is also fixed. This manipulation allowsquality surgery. At the positions where the thread is bent, the skin isnot pulled in—the bend of the thread is located subcutaneous to thelevel where the needles were separated.

BRIEF DESCRIPTION OF THE DRAWINGS

Below, the suggested invention is explained by drawings:

FIG. 1 shows a thread with protrusions of the first and second order.

FIG. 2 shows a thread with protrusions of the first and second order,arranged on one side of the thread.

FIG. 3 shows a complex design of the protrusions in the shape ofnotches.

FIG. 4 schematically shows the form of the protrusion in the shape of anotch subjected to the pressure of the tissue.

FIG. 5 shows a recommended thread for sewing a wound by the continuoustechnique.

FIG. 6 shows a thread for sewing one wound in two stages.

FIG. 7 shows the sewing of a wound with two threads on different levels.

FIG. 8 shows the sewing of a wound with one thread on different levels.

FIG. 9 shows a thread with protrusions in the shape of notches of ashaped design provided with two needles for tightening soft tissues.

FIG. 10 shows a suture material with a double needle used for tighteningsoft tissues.

FIG. 11 shows a suture material with a double double-pointed needle.

FIG. 12 shows a scheme for sewing the edges of a wound with rectangularstitches requiring large forces.

FIG. 13 shows the edges of the wound tightened with rectangular sutures.

FIG. 14 schematically shows the tightening of soft tissues in the cheekand cheekbone area.

FIG. 15 shows a double-pointed needle with a thread attached immediatelyto one of its ends.

FIG. 16 shows the tightening of tissues in the cheek area.

FIG. 17 schematically shows the tightening of tissues in the cheek andcheekbone area using a duplex needle.

DETAILED DESCRIPTION

The surgical suture material and the method of its usage are presentedin various versions of the needle and thread for carrying out surgicaland cosmetic operations.

In FIGS. 1, 2, 3, and 4, elements of the surgical thread are shown. Thethread 1 is manufactured from a metallic, polymer, or organic materialwith complex protrusions on the surfaces of two sets, the ends of thefirst set 2 being directed against the tightening direction of thethread. The first set of protrusions is situated in the tissues and isresponsible for a quality contraction of the wound edges, while thesecond set 3 is directed in the tightening direction of the thread. Thesecond set is situated above the skin and is necessary to counteract aslipping of the thread.

FIG. 4 schematically shows the effect of the force of the tissues on theshaped protrusions. To carry out the intended functions, a series ofversions of needles and threads usable in surgery and making up thesuture material is explained.

In FIG. 5, the thread 1 with the needle 4 for sewing up the wound with acontinuous suture is shown in analogy to FIGS. 1 and 2. The threadcomprises protrusions 2 and 3 of a shaped design.

FIG. 6 shows an analogous version of the thread 1 with two needles 5 andprotrusions 2 and 3 with a shaped design. This thread is a double onewhich can be divided into two individual ones for operations.

The most distinctive representation is the one in FIG. 10. It comprisesa needle 6 being temporarily combined from two needles 7 and 8 forming asingle needle with a single point 9. The shape of the combined needlecan be four-sided, rhomboid or of another form in cross-section. Thethread 10 is attached by its ends 11 and 12 to the needles 7 and 8,while the protrusions of shaped design 13 and 14 are provided on thethread from opposite sides from the centre of the thread and directedwith their ends opposite to their attachment in the needles.

The use of duplex needles when carrying out surgical and cosmeticoperations allows to reach a new quality. With the needle 6 a singlesubcutaneous puncture is made, which is deepened to the required depth,subsequently the needles 7 and 8 are divided and each is directed alonga different contour, after the needles puncture the marked points, e.g.the points where they were introduced, and the threads are tightened,the bends of the threads are sunk under the skin to the level where theneedles were divided.

Another version of the application of the suture material is shown inFIG. 11. The double-pointed needle 15 made up of the needles 16 and 17makes a single puncture at the point “A” (see FIG. 17) in the upper partof the cheekbone area, the thread 18 attached to the needle 16 with theshaped protrusions is directed along the triangular contour “A”, “B”,“C”, while the needle 15 with the second half of the thread 18 isdirected along a different contour “A₁”, “B₁”, “C₁” with the puncturesand bends of the needles. The protrusions of the shaped design are bent,embedded in the donor stock of the thread, from where they are cut out,and after the needles return and are extracted at the point “A” andafter the knot is tied, the tissues are firmly fixed in the new elevatedposition.

The sewing of the soft tissues with a double-pointed needle withprotrusions on the threads is more reliable than a tightening withsmooth threads, since the tissues are evenly distributed and fixed alongthe length of the thread, do not sag and do not slip thereon in thecourse of time.

As a version of the corresponding suture material, a thread has shapedprotrusions arranged opposite one another along its entire extension. Inthis case the thread is arranged in a flexible tube e.g. of cellophane,which is extracted from the thread canal after the operation. As aversion, the thread can be covered with resorptive material.

In FIGS. 7 and 8, versions of the sewing of a wound with threads on twolevels are shown. One version (FIG. 7) comprises two threads, the secondversion—FIG. 8—comprises one thread with different directions of theshaped protrusions.

Another version of the application of the suture material (see FIGS. 12and 13). The operation is carried out as follows. This method is usedfor sewing up wounds requiring forces for contracting the edges of awound 19 and 20, the double-pointed needle 21 with the thread with thebent protrusions of the shaped design is inserted by either point to apredetermined depth into one of the edges of the wound, subsequently theneedle 21 with the thread is moved parallel to the skin perpendicularlyto the edge of the wound at an indefinite distance from the edge of thewound, further the point is directed to the surface of the skin but notextracted entirely, leaving the second point approximately at the depthof the passage of the thread, and rotating the needle by an angle of90°, the rectangular stitch is continued, thereafter the same is carriedout at the other edge of the wound, the ends of the thread are joined toone another.

As shown in the description, the suggested invention can be widely usedin a variety of cosmetic and surgical operations, and also incombination with other surgical interventions.

The suggested surgical suture material is feasible and can be appliedwidely.

The invention claimed is:
 1. Surgical suture material comprising aneedle and a thread made of a material selected from the groupconsisting of metallic, polymer and organic materials, the thread isformed with protrusions on a surface, the needle is composed of twoneedles which are configured to be separable and temporarily affixableto one another, forming a single needle of a shape selected from thegroup consisting of four-sided, rhomboid and other shape incross-section, the two needles forming a united pointed end whenaffixed, wherein the two needles are connected with ends of the thread,wherein the ends of the thread are thereby attached to a differentneedle in the affixed and non-affixed states, wherein the protrusions onthe thread have a shaped design along an axis and are arranged onopposite sides thereof from a center, the ends of the protrusion aredirected opposite to the attachment of the thread in the needles. 2.Surgical suture material according to claim 1, wherein the needle isdouble-pointed and the thread is fixed by the end to one of a centralpart of the needle and at a distance from the pointed end of the needle,the protrusions being directed with the ends opposite to the attachmentof the thread in the needles.
 3. Surgical suture material according toclaim 2, wherein the end of the thread is fixed to the needle directlyat an end.
 4. Surgical suture material according to claim 1, wherein thethread comprises shaped protrusions applied with the aid of notches,having a length of approximately 1.5 to 5 times the diameters of thethread with a shaped design of the variable cross-section, amounting atthe basis to approximately ¼ of the diameter of the thread from thesurface and at the central part to approximately ⅓ of the diameter ofthe thread from the surface with a gradual transformation to thesharpened end of the protrusion, which allows a bending of theprotrusion in the form of a fishing hook when the thread is pulled backin the process of sewing soft tissues.